FDA.reportPublic FDA data

Simvastatin

Product NDC
71335-1905
11-digit product format
713351905
Labeler code
71335
Product ID
71335-1905_410c02d5-08d3-4fd4-8130-26de1b6daaf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078034
Marketing category
ANDA
Marketing start
2015-12-17
Substance
SIMVASTATIN
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Simvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1905-1Simvastatin30 in 1 BOTTLETABLET, FILM COATED30103
71335-1905-2Simvastatin90 in 1 BOTTLETABLET, FILM COATED90103
71335-1905-3Simvastatin120 in 1 BOTTLETABLET, FILM COATED120103
71335-1905-4Simvastatin100 in 1 BOTTLETABLET, FILM COATED100103
71335-1905-5Simvastatin60 in 1 BOTTLETABLET, FILM COATED60103
71335-1905-6Simvastatin28 in 1 BOTTLETABLET, FILM COATED28103
71335-1905-7Simvastatin10 in 1 BOTTLETABLET, FILM COATED10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1905SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240524_4277e75a-7f3b-4f35-ae56-0bbe095586a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN4277e75a-7f3b-4f35-ae56-0bbe095586a5103
314231simvastatin 10 MG Oral TabletSCD4277e75a-7f3b-4f35-ae56-0bbe095586a5103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1905-17133519050130 TABLET, FILM COATED in 1 BOTTLE (71335-1905-1) 2021-09-080000-00-00NoNoCurrent
71335-1905-27133519050290 TABLET, FILM COATED in 1 BOTTLE (71335-1905-2) 2021-09-130000-00-00NoNoCurrent
71335-1905-371335190503120 TABLET, FILM COATED in 1 BOTTLE (71335-1905-3) 2021-12-290000-00-00NoNoCurrent
71335-1905-471335190504100 TABLET, FILM COATED in 1 BOTTLE (71335-1905-4) 2021-07-190000-00-00NoNoCurrent
71335-1905-57133519050560 TABLET, FILM COATED in 1 BOTTLE (71335-1905-5) 2021-12-290000-00-00NoNoCurrent
71335-1905-67133519050628 TABLET, FILM COATED in 1 BOTTLE (71335-1905-6) 2021-12-290000-00-00NoNoCurrent
71335-1905-77133519050710 TABLET, FILM COATED in 1 BOTTLE (71335-1905-7) 2021-12-290000-00-00NoNoCurrent